Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074269
Status:
TERMINATED
Last Update Posted:
2023-06-05
First Post:
2003-12-10
Brief Title:
Allogeneic Stem Cell Transplant After ATG High-Dose Melphalan and Fludarabine for Patients With Breast Cancer
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated early due to poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving chemotherapy such as fludarabine and melphalan before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system and help destroy any remaining tumor cells graft-versus-tumor effect Giving an infusion of the donors T cells donor lymphocyte infusion after the transplant may help increase this effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving antithymocyte globulin cyclosporine and methotrexate before or after the transplant may stop this from happening
PURPOSE This phase II trial is studying how well antithymocyte globulin high-dose melphalan fludarabine and allogeneic peripheral stem cell transplant work in treating patients with metastatic adenocarcinoma of the breast
PURPOSE This phase II trial is studying how well antithymocyte globulin high-dose melphalan fludarabine and allogeneic peripheral stem cell transplant work in treating patients with metastatic adenocarcinoma of the breast
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin high-dose melphalan and fludarabine in women with chemotherapy-refractory or poor-prognosis metastatic adenocarcinoma of the breast
Determine the ability of this preparative regimen to facilitate long-term engraftment of allogeneic stem cells and lymphocytes in these patients
Determine the response in measurableevaluable disease and its temporal relationship to the preparative chemotherapy used and to the onset of clinical graft-versus-host disease GVHD in patients treated with this regimen
Secondary
Determine the progression-free and overall survival of patients treated with this regimen
Determine the tumor response and its temporal relationship to administration of high-dose chemotherapy and to the onset of GVHD in patients treated with this regimen
Determine the frequency and durability of the induction of full donor chimerism of lymphocytes in patients treated with this regimen
OUTLINE This is a nonrandomized pilot study
Nonmyeloablative preparative regimen Patients receive fludarabine IV over 30 minutes on days -8 to -4 anti-thymocyte globulin IV over 4 hours on days -7 to -4 and high-dose melphalan IV over 30 minutes on days -3 and -2
Graft-versus-host disease GVHD prophylaxis Patients receive cyclosporine IV and then orally when tolerated every 12 hours beginning on day -4 and tapered after day 42 if no GVHD occurs or after day 90 if grade I acute GVHD occurs Patients also receive methotrexate IV on days 1 3 and 6
Allogeneic peripheral blood stem cell transplantation PBSCT Patients undergo allogeneic PBSCT on day 0 Patients also receive filgrastim G-CSF IV or subcutaneously beginning on day 0 and continuing until blood counts recover
Donor lymphocyte infusion DLI Patients who show disease progression or fail to achieve full donor type T-cell chimerism at least 90 donor derived T-cells by the 90-day assessment posttransplantation and have no evidence of active GVHD may receive DLI Patients who have unresponsive disease with no active GVHD receive subsequent DLIs every 6-8 weeks
Patients are followed at 1 3 6 12 18 24 30 and 36 months
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Primary
Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin high-dose melphalan and fludarabine in women with chemotherapy-refractory or poor-prognosis metastatic adenocarcinoma of the breast
Determine the ability of this preparative regimen to facilitate long-term engraftment of allogeneic stem cells and lymphocytes in these patients
Determine the response in measurableevaluable disease and its temporal relationship to the preparative chemotherapy used and to the onset of clinical graft-versus-host disease GVHD in patients treated with this regimen
Secondary
Determine the progression-free and overall survival of patients treated with this regimen
Determine the tumor response and its temporal relationship to administration of high-dose chemotherapy and to the onset of GVHD in patients treated with this regimen
Determine the frequency and durability of the induction of full donor chimerism of lymphocytes in patients treated with this regimen
OUTLINE This is a nonrandomized pilot study
Nonmyeloablative preparative regimen Patients receive fludarabine IV over 30 minutes on days -8 to -4 anti-thymocyte globulin IV over 4 hours on days -7 to -4 and high-dose melphalan IV over 30 minutes on days -3 and -2
Graft-versus-host disease GVHD prophylaxis Patients receive cyclosporine IV and then orally when tolerated every 12 hours beginning on day -4 and tapered after day 42 if no GVHD occurs or after day 90 if grade I acute GVHD occurs Patients also receive methotrexate IV on days 1 3 and 6
Allogeneic peripheral blood stem cell transplantation PBSCT Patients undergo allogeneic PBSCT on day 0 Patients also receive filgrastim G-CSF IV or subcutaneously beginning on day 0 and continuing until blood counts recover
Donor lymphocyte infusion DLI Patients who show disease progression or fail to achieve full donor type T-cell chimerism at least 90 donor derived T-cells by the 90-day assessment posttransplantation and have no evidence of active GVHD may receive DLI Patients who have unresponsive disease with no active GVHD receive subsequent DLIs every 6-8 weeks
Patients are followed at 1 3 6 12 18 24 30 and 36 months
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000343758 | REGISTRY | PDQ Physician Data Query | None |